[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.97] [Page 137] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents Subpart C--Abbreviated Applications Sec. 314.97 Supplements and other changes to an approved abbreviated application. The applicant shall comply with the requirements of Secs. 314.70 and 314.71 regarding the submission of supplemental applications and other changes to an approved abbreviated application.